Avalus™ 40021Recalls & reported problems

Summary

The FDA's MAUDE database contains 59 adverse event reports that list this exact device (DI 00643169983182), received between Mar 15, 2018 and Sep 15, 2026 — classified as 4 deaths, 43 injuries, 12 malfunctions.

The most frequently reported specific device problem is “Inadequacy of Device Shape and/or Size” (21 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 59 reports, in the reporter's own words as published by the FDA.

• InjurySep 15, 2026Insufficient Device Problem Information

  Medtronic received information that 4 years and 8 months post implant of this 21mm aortic bioprosthetic valve, it was explanted and replaced with a new 21mm aortic bioprosthetic valve of the same model. The reason for the replacement was not reported. No additional adverse patient effects were reported.

  Patient problems: Insufficient Information

  MAUDE report 50768051 ↗
• MalfunctionSep 15, 2026Calcified

  It was reported that 7 years and 2 months post implant of this 21mm aortic bioprosthetic valve, the patient is being evaluated for a transcatheter valve-in-valve replacement. The reason for evaluation was not reported. Evidence of calcification was seen in the Left Ventricular Outflow Tract (LVOT) under the right coronary Cusp (RCC), sino-tubular junction (STJ), and anterior calcification in the the right femoral artery (RFA) and left femoral artery (LFA). No intervention or adverse patient effects were reported.

  Patient problems: Calcium Deposits/Calcification

  MAUDE report 50767831 ↗
• InjuryJun 11, 2026Intravalvular regurgitation

  IT WAS REPORTED THAT 2 YEARS AND 11 MONTHS POST IMPLANT OF THIS 21MM AORTIC BIOPROSTHETIC VALVE, THE PATIENT IS BEING EVALUATED FOR A TRANSCATHETER VALVE-IN-VALVE REPLACEMENT. THE REASON FOR EVALUATION WAS REPORTED AS REGURGITATION. NO INTERVENTION OR ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Aortic Valve Insufficiency/ Regurgitation

  MAUDE report 25468676 ↗
• MalfunctionMay 13, 2026Device Stenosis

  IT WAS REPORTED THAT 7 YEARS AND 10 MONTHS POST IMPLANT OF THIS 21MM AORTIC BIOPROSTHETIC VALVE, THE PATIENT IS BEING EVALUATED FOR A TRANSCATHETER VALVE-IN-VALVE REPLACEMENT. THE REASON FOR EVALUATION WAS REPORTED AS VALVE STENOSIS. NO INTERVENTION OR ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Aortic Valve Stenosis

  MAUDE report 25160189 ↗
• InjuryMar 12, 2026Inadequacy of Device Shape and/or Size

  MEDTRONIC RECEIVED INFORMATION THAT 5 YEARS AND 1 MONTH POST IMPLANT OF THIS AORTIC BIOPROSTHETIC VALVE, THE PATIENT IS BEING EVALUATED FOR A TRANSCATHETER VALVE-IN-VALVE REPLACEMENT. THE REASON FOR EVALUATION WAS REPORTED AS A PATIENT PROTHESIS MISMATCH ISSUE OR PPM. AN INTERVENTION IS REQUIRED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 24578497 ↗
• InjuryFeb 9, 2026Calcified

  IT WAS REPORTED THAT 4 YEARS AND 7 MONTHS POST IMPLANT OF THIS 21MM AORTIC BIOPROSTHETIC VALVE, THE PATIENT IS BEING EVALUATED FOR A TRANSCATHETER VALVE-IN-VALVE REPLACEMENT. THE REASON FOR EVALUATION WAS NOT REPORTED. EVIDENCE OF CALCIFICATION WAS SEEN IN THE THE LEFT VENTRICULAR OUTFLOW TRACT (LVOT) UNDER RIGHT CORONARY CUSP (RCC), LEFT CORONARY CUSP (LCC) AND NON-CORONARY CUSP (NCC). NO INTERVENTION OR ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Calcium Deposits/Calcification

  MAUDE report 24290061 ↗
• InjuryDec 22, 2025Calcified; Device Stenosis; Calcified; Device Stenosis

  ADDITIONAL INFORMATION RECEIVED REPORTED THAT ON (B)(6) 2026, THE PATIENT SUCCESSFULLY HAD A TRANSCATHETER VALVE-IN-VALVE REPLACEMENT. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Aortic Valve Stenosis; Calcium Deposits/Calcification; No Clinical Signs, Symptoms or Conditions

  MAUDE report 23868522 ↗
• InjuryDec 11, 2025Device Stenosis; Device Stenosis

  IT WAS REPORTED THAT 6 YEARS AND 8 MONTHS POST IMPLANT OF THIS 21MM AORTIC BIOPROSTHETIC VALVE, THE PATIENT IS BEING EVALUATED FOR A TRANSCATHETER VALVE-IN-VALVE REPLACEMENT. THE REASON FOR EVALUATION WAS REPORTED AS AORTIC STENOSIS. SUBSEQUENTLY ON THE SAME DAY (B)(6) 2025, THE PATIENT SUCCESSFULLY HAD A 23MM TRANSCATHETER VALVE-IN-VALVE REPLACEMENT. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Aortic Valve Stenosis

  MAUDE report 23776549 ↗
• InjuryDec 10, 2025Device Stenosis; Device Stenosis

  IT WAS REPORTED THAT 6 YEARS AND 11 MONTHS POST IMPLANT OF THIS 21MM AORTIC BIOPROSTHETIC VALVE, THE PATIENT IS BEING EVALUATED FOR A TRANSCATHETER VALVE-IN-VALVE REPLACEMENT. THE REASON FOR EVALUATION WAS REPORTED AS AORTIC STENOSIS. SUBSEQUENTLY ON THE SAME DAY, (B)(6) 2025 THE PATIENT SUCCESSFULLY HAD A 23MM TRANSCATHETER VALVE-IN-VALVE REPLACEMENT. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Aortic Valve Stenosis

  MAUDE report 23767461 ↗
• MalfunctionOct 17, 2025Thickening of Material; Thickening of Material

  MEDTRONIC RECEIVED INFORMATION THAT 6 YEARS AND 1 MONTH POST IMPLANT OF THIS AORTIC BIOPROSTHETIC VALVE, THE PATIENT IS BEING EVALUATED FOR A TRANSCATHETER VALVE-IN-VALVE REPLACEMENT. THE REASON FOR EVALUATION WAS NOT REPORTED. IT WAS REPORTED THAT ON EVALUATION, THE BIOPROSTHETIC VALVE LEAFLETS APPEARED THICKENED. NO INTERVENTION OR ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 23325867 ↗
• DeathSep 16, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT AN UNKNOWN DURATION POST IMPLANT OF THESE AVALUS ULTRA VALVES, THE PATIENT DIED. THE CAUSE OF DEATH WAS NOT RECEIVED. THEREFORE, RELATEDNESS OF THE DEATH TO THE AVALUS ULTRA DEVICES COULD NOT BE EXCLUDED. IT IS UNKNOWN WHETHER AN AUTOPSY WAS PERFORMED.

  Patient problems: Insufficient Information

  MAUDE report 23062896 ↗
• MalfunctionSep 11, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT 6 YEARS AND 3 MONTHS POST IMPLANT OF THIS 21MM AORTIC BIOPROSTHETIC VALVE, THE PATIENT IS BEING EVALUATED FOR A TRANSCATHETER VALVE-IN-VALVE REPLACEMENT. THE REASON FOR EVALUATION WAS NOT REPORTED. NO INTERVENTION OR PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Insufficient Information

  MAUDE report 23024713 ↗
• InjurySep 10, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  MEDTRONIC RECEIVED INFORMATION THAT THE SAME DAY POST IMPLANT OF THIS 21MM AORTIC BIOPROSTHETIC VALVE, IT WAS REPORTED THAT THE PATIENT HAD COAGULOPATHY AND HEMODYNAMIC INSTABILITY, REQUIRING MEDICATION AND TRANSFUSIONS OF 4 UNITS PACKED RED BLOOD CELLS (PRBC), 4 UNITS FRESH FROZEN PLASMA (FFP), 3 PACKS PLATELETS AND 4 UNITS CRYOPRECIPITATE. THE PATIENT WAS THEN BROUGHT BACK TO THE OPERATING ROOM FOR CONCERN OF TAMPONADE, HOWEVER TAMPONADE WAS NOT PRESENT. A HEMATOMA WAS EVACUATED AND THE PATIENT STABILIZED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Anemia; Hematoma; Hemorrhage/Blood Loss/Bleeding

  MAUDE report 23016047 ↗
• MalfunctionApr 24, 2025Unsealed Device Packaging; Unsealed Device Packaging

  IT WAS REPORTED THAT PRIOR TO USE, THE JAR WAS BROKEN AND LEAKING ON AN AVALUS VALVE. A NEW VALVE WAS USED INSTEAD. THE DEVICE WAS INSPECTED PRIOR TO USE, AND THE PROCEDURE WAS NOT DELAYED AS A RESULT OF THE ISSUE. IT WAS REPORTED THAT THE VALVE WAS STORED IN A STORAGE, IN THE OPERATING ROOM AND DID NOT APPEAR DAMAGED UPON ARRIVAL. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21900157 ↗
• InjuryApr 1, 2025Patient Device Interaction Problem; Device Stenosis; Patient Device Interaction Problem; Device Stenosis

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED HEART FAILURE AND HEMODYNAMIC INSTABILITY, AS WELL AS CONGESTIVE HEART FAILURE (CHF) AS SOCIATED WITH THE IMPLANTED VALVE 40021 MODEL 400 AOR. THE PATIENT SUFFERED FROM ACUTE ON CHRONIC DIASTOLIC HEART FAILURE, CLASS II¿3, AND PROFOUND LETHARGY, WITH SEVERE BIOPROSTHETIC AORTIC VALVE STENOSIS PER DOPPLER CRITERIA. PLANNED TREATMENTS INCLUDED A CARDIA C COMPUTED TOMOGRAPHY ANGIOGRAPHY (CTA), TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE), AND CARDIAC CATHETERIZATION TO RULE OUT SIGNIFICANT CORONARY DISEASE BEFORE CONSIDERING AORTIC VALVE REPLACEMENT. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Aortic Valve Stenosis; Heart Failure/Congestive Heart Failure

  MAUDE report 21739116 ↗
• InjuryMar 28, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT A 21MM AORTIC TISSUE VALVE, IMPLANTED IN THE PULMONARY POSITION ON (B)(6) 2019, AND A NEW PULMONARY TRANSC ATHETER VALVE WAS IMPLANTED VALVE-IN-VALVE ON (B)(6) 2025. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Insufficient Information

  MAUDE report 21717704 ↗
• MalfunctionMar 19, 2025Device Stenosis; Device Stenosis

  IT WAS REPORTED THAT POST IMPLANT OF THIS AVALUS AORTIC VALVE, THE PATIENT IS BEING EVALUATED FOR A VALVE-IN-VALVE REPLACEMENT. THE REASON FOR EVALUATION WAS REPORTED AS VALVE STENOSIS. NO INTERVENTION OR ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Aortic Valve Stenosis

  MAUDE report 21641010 ↗
• InjuryFeb 20, 2025Gradient Increase; Insufficient Device Problem Information; Gradient Increase; Insufficient Device Problem Information

  IT WAS REPORTED THAT POST IMPLANT OF THIS AVALUS AORTIC VALVE, THE PATIENT IS BEING EVALUATED FOR A TRANSCATHETER VALVE-IN-VALVE REPLACEMENT. THE REASON FOR EVALUATION WAS NOT REPORTED. NO INTERVENTION OR ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21419985 ↗
• MalfunctionJan 29, 2025Gradient Increase; Inadequacy of Device Shape and/or Size; Gradient Increase; Inadequacy of Device Shape and/or Size

  MEDTRONIC RECEIVED INFORMATION THAT 1 YEAR AND 3 MONTHS POST IMPLANT OF THIS AORTIC BIOPROSTHETIC VALVE, THE PATIENT WAS EXPERIENCING INCREASED GRADIENTS OF 20-21MMHG. AT 2 YEARS AND 7 MONTHS POST IMPLANT, THE GRADIENTS INCREASED TO 23MMHG AND 1 YEAR FOLLOWING THAT, THE GRADIENTS WERE UP TO 24MMHG. AT 4 YEARS AND 2 MONTHS POST IMPLANT, THE MOST GRADIENTS WERE OBSERVED TO BE BETWEEN 38MMHG AND 41MMHG. THE PATIENT IS BEING EVALUATED FOR A TRANSCATHETER VALVE-IN-VALVE REPLACEMENT. THE REASON FOR EVALUATION WAS REPORTED AS PATIENT PROSTHESIS MISMATCH. NO INTERVENTION OR ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 21267999 ↗
• InjuryJan 28, 2025Device Stenosis; Device Stenosis

  IT WAS REPORTED THAT A PATIENT WITH A HISTORY OF SEVERE MITRAL ANNULAR CALCIFICATION AND PREVIOUS SURGICAL AORTIC VALVE REPLACEMENT (SAVR) EXPERIENCED A VALVE PERFORMANCE ISSUE AND VALVE STENOSIS WITH THE MEDTRONIC AVALUS BIOPROSTHETIC VALVE. THE INTERVENTION INVOLVED THE REPLACEMENT OF THE MEDTRONIC AVALUS BIOPROSTHETIC VALVE WITH A TRANSCATHETER VALVE IMPLANTED IN A VALVE-IN-VALVE PROCEDURE. THE PATIENT OUTCOME WAS REPORTED AS ALIVE WITH NO INJURY. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Aortic Valve Stenosis

  MAUDE report 21254219 ↗
• InjuryOct 23, 2024Patient Device Interaction Problem; Patient Device Interaction Problem

  MEDTRONIC RECEIVED INFORMATION THAT 1 DAY POST IMPLANT OF THIS AORTIC BIOPROSTHETIC VALVE, A PERMANENT PACEMAKER WAS IMPLANTED. THE REASON FOR THE PERMANENT PACEMAKER WAS REPORTED AS 3RD DEGREE ATRIOVENTRICULAR BLOCK OR COMPLETE HEART BLOCK. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 20517341 ↗
• InjuryOct 9, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT DURING THE IMPLANT OF THIS 21MM AORTIC BIOPROSTHETIC VALVE, IT WAS EXPLANTED AND REPLACED WITH A 23MM VALVE OF THE SAME MODEL. THE REASON FOR THE REPLACEMENT WAS NOT REPORTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 20405952 ↗
• InjuryJul 18, 2024Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  MEDTRONIC RECEIVED INFORMATION THAT DURING THE IMPLANT OF THIS 21MM AORTIC BIOPROSTHETIC VALVE, IT WAS EXPLANTED AND REPLACED WITH A 19MM VALVE OF THE SAME MODEL. THE REASON FOR THE REPLACEMENT WAS REPORTED AS A SIZING ISSUE. IT WAS ALSO REPORTED THAT BEFORE PUTTING SUTURES IN THE VALVE, THE HEALTH CARE PROFESSIONAL (HCP) FELT THERE MAY BE SOMETHING OFF ABOUT THE VALVE AND THAT IT WAS MUCH LARGER THAN THE SIZER. IT WAS ALSO REPORTED THAT BOTH THE BARREL END AND THE REPLICA END OF THE SIZER WERE USED. IT WAS ALSO REPORTED THAT THE ANNULUS WAS NOT FELT TO BE BETWEEN TWO DIFFERENT VALVE SIZES, AND THE BODY SURFACE AREA (BSA) CHART ALONG WITH PLEDGETS WERE NOT USED FOR VALVE SIZING. IT WAS ALSO REPORTED THAT THE HCP TRIED TO SEAT THE LARGER VALVE BEFORE PUTTING SUTURES THROUGH THE VALVE CUFF, AS HE STATED THE VALVE WAS MUCH LARGER THAN THE SIZER REFLECTED AND CHOSE THE SMALLER SIZED VALVE AS THE LARGER WOULD MOST LIKELY NOT FIT. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19773874 ↗
• InjuryJun 19, 2024Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem; Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem

  MEDTRONIC RECEIVED INFORMATION THAT 9 MONTHS POST IMPLANT OF THIS 21MM AORTIC BIOPROSTHETIC VALVE, A PERMANENT PACEMAKER WAS IMPLANTED. THE REASON FOR THE PERMANENT PACEMAKER WAS REPORTED AS 2ND DEGREE ATRIOVENTRICULAR (AV) BLOCK. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Non specific EKG/ECG Changes

  MAUDE report 19566116 ↗
• DeathApr 29, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT 1 DAY POST IMPLANT OF THIS 21MM AORTIC BIOPROSTHETIC VALVE, THE PATIENT DIED. THE CAUSE OF DEATH WAS RECEIVED AS CARDIOGENIC SHOCK, STAPHYLOCOCCUS AUREUS BACTEREMIA AND SEPSIS. THEREFORE, RELATEDNESS OF THE DEATH TO THE 21MM AORTIC BIOPROSTHETIC VALVE COULD NOT BE EXCLUDED. IT IS UNKNOWN WHETHER AN AUTOPSY WAS PERFORMED.

  Patient problems: Cardiogenic Shock; Sepsis

  MAUDE report 19202869 ↗